Leadless
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Po několik desítek let je zavedení transvenózní trvalé kardiostimulace považováno za zlatý standard léčby nemocných s bradyarytmiemi. Nicméně samy transvenózní elektrody mohou být zdrojem komplikací stejně jako subkutánní uložení vlastního kardiostimulátoru. Shrnujeme současný pohled na nově zaváděnou léčbu pomocí bezdrátových kardiostimulátorů implantovaných zcela intrakardiálně, včetně analýzy prvního použití v humánní medicíně u nemocných indikovaných k jednodutinové komorové stimulaci. S využitím transfemorálního přístupu se stimulační systém implantuje do oblasti apikoseptální části pravé komory srdeční. Popisujeme technické a klinické aspekty nově zaváděné technologie. Dva rozdílné stimulační systémy pro kompletně bezdrátovou kardiostimulaci jsou v současné době implantovány nemocným. Získaná data prokazují velmi stabilní elektrické parametry implantované technologie (stimulační práh, snímání elektrického potenciálu a stimulační odpor) nebo dokonce jejich progresivní zlepšení v době sledování po implantaci. Diskutujeme také potenciální přínos pro budoucnost trvalé kardiostimulace; shrnujeme, že doposud získaná data přesvědčivě prokazují velmi dobré parametry nově zaváděné bezdrátově kardiostimulace.
For several decades, the traditional transvenous approach to permanent cardiac pacing has been accepted as the gold standard approach to the treatment of patients with bradycardias. However, it can be associated with significant acute and chronic complications related partly to either the insertion of the transvenous lead or subcutaneous placement of the pacemaker device. We summarise the current results of novel self‑contained leadless cardiac pacemakers in the first‑in‑man and subsequent series of feasibility studies in patients indicated for ventricular rate‑responsive pacing (VVI). Using a femoral venous approach, the device is implanted in the right ventricular apical septum region. We describe the technical and clinical characterisation of this innovative technology. Two different systems of leadless pacemakers are currently implanted in patients. Up to now, the electrical parameters, such as pacing thresholds, sensing parameters, and pacing impedances, either improved or remained stable within the accepted range. We also discuss the potential benefit for the future of permanent cardiac stimulation, but in summary, all available data demonstrate the feasibility of leadless cardiac pacing.
- Klíčová slova
- trvalá kardiostimulace, Nanostim LCP, Micra TPS, bezdrátový kardiostimulátor,
- MeSH
- bezdrátová technologie * přístrojové vybavení MeSH
- bezpečnost vybavení MeSH
- design vybavení MeSH
- endokard MeSH
- kardiostimulace umělá * dějiny metody trendy MeSH
- kardiostimulátor MeSH
- lidé MeSH
- mikroelektromechanické systémy * přístrojové vybavení MeSH
- miniaturizace MeSH
- srdeční arytmie terapie MeSH
- ultrasonografie MeSH
- ultrazvuk MeSH
- Check Tag
- lidé MeSH
BACKGROUND: Single-chamber ventricular leadless pacemakers do not support atrial pacing or consistent atrioventricular synchrony. A dual-chamber leadless pacemaker system consisting of two devices implanted percutaneously, one in the right atrium and one in the right ventricle, would make leadless pacemaker therapy a treatment option for a wider range of indications. METHODS: We conducted a prospective, multicenter, single-group study to evaluate the safety and performance of a dual-chamber leadless pacemaker system. Patients with a conventional indication for dual-chamber pacing were eligible for participation. The primary safety end point was freedom from complications (i.e., device- or procedure-related serious adverse events) at 90 days. The first primary performance end point was a combination of adequate atrial capture threshold and sensing amplitude at 3 months. The second primary performance end point was at least 70% atrioventricular synchrony at 3 months while the patient was sitting. RESULTS: Among the 300 patients enrolled, 190 (63.3%) had sinus-node dysfunction and 100 (33.3%) had atrioventricular block as the primary pacing indication. The implantation procedure was successful (i.e., two functioning leadless pacemakers were implanted and had established implant-to-implant communication) in 295 patients (98.3%). A total of 35 device- or procedure-related serious adverse events occurred in 29 patients. The primary safety end point was met in 271 patients (90.3%; 95% confidence interval [CI], 87.0 to 93.7), which exceeded the performance goal of 78% (P<0.001). The first primary performance end point was met in 90.2% of the patients (95% CI, 86.8 to 93.6), which exceeded the performance goal of 82.5% (P<0.001). The mean (±SD) atrial capture threshold was 0.82±0.70 V, and the mean P-wave amplitude was 3.58±1.88 mV. Of the 21 patients (7%) with a P-wave amplitude of less than 1.0 mV, none required device revision for inadequate sensing. At least 70% atrioventricular synchrony was achieved in 97.3% of the patients (95% CI, 95.4 to 99.3), which exceeded the performance goal of 83% (P<0.001). CONCLUSIONS: The dual-chamber leadless pacemaker system met the primary safety end point and provided atrial pacing and reliable atrioventricular synchrony for 3 months after implantation. (Funded by Abbott Medical; Aveir DR i2i ClinicalTrials.gov number, NCT05252702.).
- MeSH
- atrioventrikulární blokáda terapie MeSH
- fibrilace síní terapie etiologie MeSH
- kardiostimulace umělá * škodlivé účinky metody MeSH
- kardiostimulátor * škodlivé účinky MeSH
- lidé MeSH
- následné studie MeSH
- prospektivní studie MeSH
- srdeční arytmie * terapie MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- klinická studie MeSH
- multicentrická studie MeSH
Leadless pacemakers (LPs) are self-contained pacemakers implanted inside the heart, providing a clinical strategy of pacing without pacemaker leads or a subcutaneous pocket. From an experimental therapy first used clinically in 2012, a decade later this technology is an established treatment option. Because of technologic advances and growing evidence, LPs are increasingly being used. Herein, the experience gained from a decade of leadless pacing is reviewed. We cover the safety and efficacy of single-chamber LPs, including comparisons with transvenous pacemakers and various models, and the initial clinical results of the first dual-chamber LP system. Furthermore, evidence and considerations regarding the optimal replacement strategy will be covered. Finally, we discuss future device developments that may broaden indications, such as LPs communicating with subcutaneous implantable cardiac defibrillators and energy-harvesting LPs.
- MeSH
- design vybavení * MeSH
- kardiostimulace umělá * metody trendy MeSH
- kardiostimulátor * trendy MeSH
- lidé MeSH
- srdeční arytmie terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- přehledy MeSH
Traditional transvenous approach for permanent cardiac pacing can be associated with significant acute and chronic complications related partly to either the insertion of transvenous lead or subcutaneous placement of pacemaker device. We summarize the current status of a novel self-contained leadless cardiac pacemaker in the first-in-human and subsequent series of feasibility studies in patients indicated for ventricular rate-responsive pacing (VVI). Using a femoral venous approach, the device is implanted at the right ventricular apical septum region. We describe the technical and clinical characterization of this innovative technology. Two different systems of leadless pacemakers are currently implanted to the patients. Up to now, the electrical parameters, such as pacing thresholds, sensing parameters, and pacing impedances, either improved or remained stable within the accepted range. In this chapter, we also discuss the potential benefit for the future, but in summary, all available data demonstrate the feasibility of leadless cardiac pacing.
BACKGROUND: The subcutaneous implantable cardioverter-defibrillator (ICD) is associated with fewer lead-related complications than a transvenous ICD; however, the subcutaneous ICD cannot provide bradycardia and antitachycardia pacing. Whether a modular pacing-defibrillator system comprising a leadless pacemaker in wireless communication with a subcutaneous ICD to provide antitachycardia and bradycardia pacing is safe remains unknown. METHODS: We conducted a multinational, single-group study that enrolled patients at risk for sudden death from ventricular arrhythmias and followed them for 6 months after implantation of a modular pacemaker-defibrillator system. The safety end point was freedom from leadless pacemaker-related major complications, evaluated against a performance goal of 86%. The two primary performance end points were successful communication between the pacemaker and the ICD (performance goal, 88%) and a pacing threshold of up to 2.0 V at a 0.4-msec pulse width (performance goal, 80%). RESULTS: We enrolled 293 patients, 162 of whom were in the 6-month end-point cohort and 151 of whom completed the 6-month follow-up period. The mean age of the patients was 60 years, 16.7% were women, and the mean (±SD) left ventricular ejection fraction was 33.1±12.6%. The percentage of patients who were free from leadless pacemaker-related major complications was 97.5%, which exceeded the prespecified performance goal. Wireless-device communication was successful in 98.8% of communication tests, which exceeded the prespecified goal. Of 151 patients, 147 (97.4%) had pacing thresholds of 2.0 V or less, which exceeded the prespecified goal. The percentage of episodes of arrhythmia that were successfully terminated by antitachycardia pacing was 61.3%, and there were no episodes for which antitachycardia pacing was not delivered owing to communication failure. Of 162 patients, 8 died (4.9%); none of the deaths were deemed to be related to arrhythmias or the implantation procedure. CONCLUSIONS: The leadless pacemaker in wireless communication with a subcutaneous ICD exceeded performance goals for freedom from major complications related to the leadless pacemaker, for communication between the leadless pacemaker and subcutaneous ICD, and for the percentage of patients with a pacing threshold up to 2.0 V at a 0.4-msec pulse width at 6 months. (Funded by Boston Scientific; MODULAR ATP ClinicalTrials.gov NCT04798768.).
- MeSH
- bezdrátová technologie MeSH
- bradykardie * terapie MeSH
- defibrilátory implantabilní * škodlivé účinky MeSH
- design vybavení MeSH
- kardiostimulace umělá škodlivé účinky metody MeSH
- kardiostimulátor * škodlivé účinky MeSH
- lidé středního věku MeSH
- lidé MeSH
- náhlá srdeční smrt * prevence a kontrola etiologie MeSH
- následné studie MeSH
- senioři MeSH
- srdeční arytmie * komplikace terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky MeSH
- multicentrická studie MeSH
Despite significant advances in battery longevity, lead performance, and programming features since the first implanted permanent pacemaker was developed, the basic design of cardiac pacemakers has remained relatively unchanged over the past 50 years. Because of inherent limitations in their design, conventional (transvenous) pacemakers are prone to multiple potential short- and long-term complications. Accordingly, there has been intense interest in a system able to provide the symptomatic and potentially lifesaving therapies of cardiac pacemakers while mitigating many of the risks associated with their weakest link-the transvenous lead. Leadless cardiac pacing represents the future of cardiac pacing systems, similar to the transition that occurred from the use of epicardial pacing systems to the familiar transvenous systems of today. This review summarizes the current evidence and potential benefits of leadless pacing systems, which are either commercially available (in Europe) or under clinical investigation.
- MeSH
- bezpečnost vybavení MeSH
- design vybavení MeSH
- implantované elektrody trendy MeSH
- kardiostimulace umělá metody mortalita MeSH
- kardiostimulátor * MeSH
- lidé MeSH
- míra přežití MeSH
- předpověď MeSH
- srdeční arytmie mortalita terapie MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- přehledy MeSH
- Geografické názvy
- Evropa MeSH
BACKGROUND: Leadless cardiac pacemakers have emerged as a safe and effective alternative to conventional transvenous single-chamber ventricular pacemakers. Herein, we report a multicenter experience on the feasibility and safety of acute retrieval (<6 weeks) and chronic retrieval (>6 weeks) of the leadless cardiac pacemaker in humans. METHODS AND RESULTS: This study included patients enrolled in 3 multicenter trials, who received a leadless cardiac pacemaker implant and who subsequently underwent a device removal attempt. The overall leadless pacemaker retrieval success rate was 94%: for patients whose leadless cardiac pacemaker had been implanted for <6 weeks (acute retrieval cohort), complete retrieval was achieved in 100% (n=5/5); for those implanted for ≥ 6 weeks (chronic retrieval cohort), retrieval was achieved in 91% (n=10/11) of patients. The mean duration of time from implant to retrieval attempt was 346 days (range, 88-1188 days) in the chronic retrieval cohort, and nearly two thirds (n=7; 63%) had been implanted for >6 months before the retrieval attempt. There were no procedure-related adverse events at 30 days post retrieval procedure. CONCLUSIONS: This multicenter experience demonstrated the feasibility and safety of retrieving a chronically implanted single-chamber (right ventricle) active fixation leadless pacemaker. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifiers: NCT02051972, NCT02030418, and NCT01700244.
- MeSH
- bezpečnost pacientů MeSH
- design vybavení MeSH
- kardiostimulátor škodlivé účinky MeSH
- lidé MeSH
- odstranění implantátu * MeSH
- senioři MeSH
- srdeční arytmie terapie MeSH
- studie proveditelnosti MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky MeSH
- multicentrická studie MeSH
BACKGROUND: A leadless intracardiac transcatheter pacing system has been designed to avoid the need for a pacemaker pocket and transvenous lead. METHODS: In a prospective multicenter study without controls, a transcatheter pacemaker was implanted in patients who had guideline-based indications for ventricular pacing. The analysis of the primary end points began when 300 patients reached 6 months of follow-up. The primary safety end point was freedom from system-related or procedure-related major complications. The primary efficacy end point was the percentage of patients with low and stable pacing capture thresholds at 6 months (≤2.0 V at a pulse width of 0.24 msec and an increase of ≤1.5 V from the time of implantation). The safety and efficacy end points were evaluated against performance goals (based on historical data) of 83% and 80%, respectively. We also performed a post hoc analysis in which the rates of major complications were compared with those in a control cohort of 2667 patients with transvenous pacemakers from six previously published studies. RESULTS: The device was successfully implanted in 719 of 725 patients (99.2%). The Kaplan-Meier estimate of the rate of the primary safety end point was 96.0% (95% confidence interval [CI], 93.9 to 97.3; P<0.001 for the comparison with the safety performance goal of 83%); there were 28 major complications in 25 of 725 patients, and no dislodgements. The rate of the primary efficacy end point was 98.3% (95% CI, 96.1 to 99.5; P<0.001 for the comparison with the efficacy performance goal of 80%) among 292 of 297 patients with paired 6-month data. Although there were 28 major complications in 25 patients, patients with transcatheter pacemakers had significantly fewer major complications than did the control patients (hazard ratio, 0.49; 95% CI, 0.33 to 0.75; P=0.001). CONCLUSIONS: In this historical comparison study, the transcatheter pacemaker met the prespecified safety and efficacy goals; it had a safety profile similar to that of a transvenous system while providing low and stable pacing thresholds. (Funded by Medtronic; Micra Transcatheter Pacing Study ClinicalTrials.gov number, NCT02004873.).
- MeSH
- bezpečnost vybavení MeSH
- design vybavení MeSH
- dospělí MeSH
- implantované elektrody MeSH
- Kaplanův-Meierův odhad MeSH
- kardiostimulátor * škodlivé účinky MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladý dospělý MeSH
- prospektivní studie MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- srdeční arytmie terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- MeSH
- bezdrátová technologie MeSH
- kardiostimulátor MeSH
- lidé MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- novinové články MeSH
